FDA Device

AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use.

Hazard

An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.

What You Should Do

Remedy

The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.

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Products

AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
UPC
46329Q101, 47118Q101, 48063Q101, 48065Q101, 49341Q101, 49559Q101

Units Affected

11530 kits

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